Adult Dosing

Irritable bowel syndrome

• 1-2 tabs PO tid-qid
• Alt 1 Etabs bid
• Alt 5-10 mL elixir tid-qid

Duodenal ulcer

• 1-2 tabs PO tid-qid
• Alt 1 Etabs bid
• Alt 5-10 mL elixir tid-qid

Acute enterocolitis

• 1-2 tabs PO tid-qid
• Alt 1 Etabs bid
• Alt 5-10 mL elixir tid-qid

Pediatric Dosing

• Safety and efficacy in pediatrics for extended release tablets is not established

Irritable bowel syndrome

• 4.5-9.0 kg
• 0.5 mL PO q4 hrs; Alt: 0.75 mL q6 hrs

• 9.1-13.5 kg
• 1 mL PO q4 hrs; Alt: 1.5 mL q6 hrs

• 13.6-22.6 kg
• 1.5 mL PO q4 hrs; Alt: 2 mL q6 hrs

• 22.7-33.9 kg
• 2.5 mL PO q4 hrs; Alt: 3.75 mL q6 hrs

• 34-45.3 kg
• 3.75 mL PO q4 hrs; Alt: 5 mL q6 hrs

• >45.4 kg
• 5 mL PO q4 hrs; Alt: 7.5 mL q6 hrs; 1 tab q4 hrs

Duodenal ulcer

• 4.5-9.0 kg
• 0.5 mL PO q4 hrs; Alt: 0.75 mL q6 hrs

• 9.1-13.5 kg
• 1 mL PO q4 hrs; Alt: 1.5 mL q6 hrs

• 13.6-22.6 kg
• 1.5 mL PO q4 hrs; Alt: 2 mL q6 hrs

• 22.7-33.9 kg
• 2.5 mL PO q4 hrs; Alt: 3.75 mL q6 hrs

• 34-45.3 kg
• 3.75 mL PO q4 hrs; Alt: 5 mL q6 hrs

• >45.4 kg
• 5 mL PO q4 hrs; Alt: 7.5 mL q 6hrs; 1 tab q4 hrs

Acute enterocolitis

• 4.5-9.0 kg
• 0.5 mL PO q4 hrs; Alt: 0.75 mL q6 hrs

• 9.1-13.5 kg
• 1 mL PO q4 hrs; Alt: 1.5 mL q6 hrs

• 13.6-22.6 kg
• 1.5 mL PO q4 hrs; Alt: 2 mL q6 hrs

• 22.7-33.9 kg
• 2.5 mL PO q4 hrs; Alt: 3.75 mL q6 hrs

• 34-45.3 kg
• 3.75 mL PO q4 hrs; Alt: 5 mL q6 hrs

• >45.4 kg
• 5 mL PO q4 hrs; Alt: 7.5 mL q6 hrs; 1 tab q4 hrs

• Note: Individualize dosage

[Outline]

• Adult Dosing
• Pediatric Dosing

• Adjunctive therapy for irritable bowel syndrome and duodenal ulcer
• Treatment of acute enterocolitis

• Hypersensitivity to any of the ingredients of the product
• Obstructive uropathy
• GI obstruction
• Paralytic ileus
• Severe ulcerative colitis
• Toxic megacolon or ileus
• Hiatal hernia with reflux esophagitis
• Biliary disease
• Intestinal atony in geriatrics
• Debilitated patients
• Myasthenia gravis
• Acute hemorrhage with unstable cardiovascular status
• Glaucoma
• Acute intermittent porphyria
• Restlessness and excitement with use of phenobarbital
• History of addiction
• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Use with caution; dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Decrease start dose; dose adjustments not defined

See Supplemental Patient Information

• Conclusive evidence on the effectiveness of anticholinergic/antispasmodic drugs in the healing of a duodenal ulcer or a decrease in the rate of occurrence or preventing complications has not been established
• Heat prostration have occurred at high environmental temperatures with belladonna alkaloids; fever and heatstroke have occurred due to decreased sweating
• Consider diarrhea as an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; therapy with this drug is inappropriate and possibly harmful under such circumstances
• Drowsiness or blurred vision have occurred
• Phenobarbital component decreases the effect of anticoagulants and necessitates higher doses of the anticoagulant for optimal effect; on discontinuing therapy the dose of the anticoagulant needs to be decreased
• Avoid administering to patients with history of physical and/or psychological dependence and in individuals known to be addiction prone
• May produce a delay in gastric emptying, complicating the management of gastric ulcer

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• GI ulcer
• CAD
• CHF
• Arrhythmias
• Hypertension
• Hyperthyroidism
• Autonomic neuropathy
• High environmental temperature
• Biliary tract disease

Supplemental Patient Information

• Advise patients to avoid engaging in activities requiring mental alertness such as operating a hazardous machinery or driving an automobile

Donnatal interacts with :

	Aricept
	Aricept ODT
	Donepezil
	Exelon
	Galantamine
	Razadyne
	Razadyne ER
	Rivastigmine

Pregnancy Category:C

Breastfeeding: Literature unavailable on the use of atropine during breastfeeding. Prolong use of atropine might reduce milk production/letdown, but an ophthalmic dose is unlikely to interfere with breastfeeding. During prolonged use, observe for signs of decreased lactation such as insatiety, poor weight gain. Inter- and intra patient variability exists in excretion of phenobarbital into breastmilk. Phenobarbital in breastmilk decreases withdrawal symptoms in infants who were exposed in utero, but can also cause drowsiness in some infants, especially when used with other sedatives. Not necessarily a reason to discontinue breastfeeding. Monitor infants for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of psychotropic drugs. Sometimes limit breastfeeding or discontinue because of excessive drowsiness and poor weight gain. If there is concern, infant serum concentrations of phenobarbital can be obtained. Measure infant serum level to rule out toxicity if there is a concern. No information is available on the use of scopolamine during breastfeeding. Long term use might suppress lactation. A single systemic dose is unlikely to interfere with breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT). Atropine and scopolamine are compatible and considered safe with breastfeeding based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776 last accessed 30 December 2010).

• CV: Bradycardia, flushing, palpitations, tachycardia
• CNS: Headache, CNS stimulation, confusion, dizziness, drowsiness, insomnia, excitement
• DERM: Urticaria, decreased sweating
• EENT: Blurred vision, cycloplegia, mydriasis, increased IOP, mydriasis
• GI: Bloated feeling, constipation, dysphagia, heartburn, nausea, paralytic ileus, vomiting, xerostomia, loss of taste, constipation, antral stasis
• GU: Impotence, urinary hesitancy, urinary retention
• MUSC: Musculoskeletal pain
• MISC: Severe hypersensitivity reaction, anaphylaxis, suppression of lactation

Atropine

• Antimuscarinic; inhibits the muscarinic actions of acetylcholine and other cholinergic stimuli at postganglionic cholinergic receptors and on smooth muscles, which respond to endogenous acetylcholine but are not so innervated
• Metabolized by liver
• Excreted in urine (13%-50%unchanged)
• Half-life:
• >2 yrs: 2.5 +/- 1.2
• Adults: 3 hrs
• Geriatrics: 10.0 +/- 7.3 hrs

Hyoscyamine

• Belladonna alkaloid; competes favorably with acetylcholine for binding at muscarinic receptors in the salivary, bronchial, and sweat glands as well as in the eye, heart, and gastrointestinal tract; results in a reduction in salivary, bronchial, gastric and sweat gland secretions, mydriasis, cycloplegia, change in heart rate, contraction of the bladder detrusor muscle and of the gastrointestinal smooth muscle, and decreases gastrointestinal motility
• Well absorbed
• Metabolized by liver
• Excreted in urine (30-50% unchanged)
• Half-life: 2-3.5 hrs, 7.5 hrs (ER form)

Phenobarbital

• Sedative and hypnotic; induces depression of sensory cortex, decreases motor activity, alters cerebellar function and produces drowsiness, sedation, and hypnosis
• Metabolized by liver; CYP450: CYP2C19
• Excreted in urine (25-50% unchanged)
• Half-life: 79 hrs

Scopolamine

• Anticholinergic; antagonizes acetylcholine receptors; competitively inhibits postganglionic muscarinic receptor sites of the parasympathetic nervous system and smooth muscles responding to acetylcholine
• Metabolized by the liver; CYP450: Unknown
• Renally excreted (<5% unchanged)
• Half-life: 8 hrs

US Trade Name(s)

• Donnatal
• Donnatal extentabs

US Availability

Donnatal (atropine/hyoscyamine/phenobarbital/scopolamine)

• TABS: 0.0194 mg/0.1037 mg/16.2 mg/0.0065 mg
• ELIXIR: [0.0194 mg/0.1037 mg/16.2 mg/0.0065 mg]/5 mL

Donnatal extentabs (atropine/hyoscyamine/phenobarbital/scopolamine)

• ETABS: 0.0582 mg/0.3111 mg/48.6 mg/0.0195 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Gastrointestinal

Anticholinergics/Antispasmodics (GI)

Pricing data from www.DrugStore.com in U.S.A.

• Donnatal TABS [Bottle] (PBM PHARMACEUTICALS)
  60 = $78.99
  180 = $211.97
• Donnatal 16.2 MG/5ML ELIX [Bottle] (PBM PHARMACEUTICALS)
  118 5ml = $33.99
  354 5ml = $97.97
• Donnatal Extentabs TBCR [Bottle] (PBM PHARMACEUTICALS)
  30 = $67.99
  90 = $180.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.